BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FITGUARD

    MDR report key: 24775479 · Received April 3, 2026

    Report

    Report Number
    1417592-2026-00311
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 1, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    LZA
    UDI-DI
    10888277414204
    PMA / PMN Number
    K240051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE WORKING WITH AN ISOLATION PT ON CA9, I HAD ALL NECESSARY PPE DONNED. PARTWAY THROUGH SESSION, I NOTICED THE THUMB FINGER ON MY R MEDIUM GLOVE WAS TORN WITHOUT ANY EVENT PRECIPITATING IT. I DONNED ANOTHER GLOVE ON TOP TO FINISH SESSION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    WHILE WORKING WITH AN ISOLATION PT ON CA9, I HAD ALL NECESSARY PPE DONNED. PARTWAY THROUGH SESSION, I NOTICED THE THUMB FINGER ON MY R MEDIUM GLOVE WAS TORN WITHOUT ANY EVENT PRECIPITATING IT. I DONNED ANOTHER GLOVE ON TOP TO FINISH SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834730 FITGUARD GLOVE,EXAM,NITRILE,PF,SELECT,MD LZA MEDLINE INDUSTRIES, LP 10888277414204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown